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Regulatory Affairs Manager

at McKesson Corporation in Chicago, Illinois, United States

Job Description

McKesson is in the business of better health, and we touch the lives of patients in virtually every aspect of healthcare. We partner with payors, hospitals, physician offices, pharmacies, pharmaceutical companies, and others across the spectrum of care to build healthier organizations that deliver better care to patients in every setting. We believe in the importance of strong, vital organizations because we know that patients can only be healthy when our system is healthy.
Every single McKesson employee contributes to our mission-by joining McKesson you act as a catalyst in a chain of events that helps millions of people all over the globe. Talented, compassionate people are the future of our company-and of healthcare. At McKesson, you'll collaborate on the products and solutions that help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that's vital to us all.
We understand the importance of a system that works together. Your expertise, drive and passion can help us improve everything we touch, from providers to payors to pharmacies. Join our team of leaders to begin a rewarding career.
Wherever you contribute here at McKesson, you will have the ability to make a real impact in the lives of others.

CURRENT NEED

We are seeking a Regulatory Affairs Manager. This role is a remote work-from-home position.

This role's primary responsibility is to analyze customer data and evaluate customers of McKesson's Pharmaceutical Solutions and Services in accordance with McKesson's Controlled Substances Monitoring Program (CSMP) in connection with manufacturer suspicious order monitoring programs. This position will principally support the Director of Regulatory Affairs (DRA) responsible for Manufacturer Engagements and also conduct customer due diligence reviews and other customer evaluations as assigned. This position reports to the Senior Director, Central Support Team, Regulatory This position will require interaction and partnership with internal teams, report-writing and data analysis, and interaction with other team members to evaluate findings from the aforementioned activities.

Key Responsibilities

Review and analyze data necessary to evaluate and respond to manufacturer inquiries and identify/validate controlled substance trends and sourcing profiles.
Prepare written reports to document reviews and statistical analysis.
Engage with account managers and customers, as well as internal team personnel as needed to support CSMP process.
Perform customer due diligence reviews that include assessments of prospective customers and ongoing assessments of current customers.
Conduct customer site visits as necessary to support CSMP processes.
Drive CSMP process awareness and communication with relevant stakeholders.
Seek opportunities to improve CSMP operational excellence through people, processes, or technology.

Minimum Requirements
Four-year degree in related field or equivalent experience.

Critical Skills
Multiple years' experience with responsibility for regulatory compliance in the supply chain for the pharmaceutical industry.
A depth of understanding of retail pharmacy operations, controlled substance compliance and diversion control programs.
Ability to learn quickly and work effectively in fast-paced environments.
Ability to collaborate with various teams.
Ability to make strategic, logic-based and educated decisions leveraging data, analysis, and information from a variety of sources.
People engagement and relationship building skills.
Specialized Knowledge/Skills - Possess a working knowledge of Federal and State governmental regulations pertaining to controlled substance compliance.
Advanced proficiency with MS Office (Word, PowerPoint, Excel).
Experience with Tableau, SAP, Salesforce, and Smartsheet.

Additional Skills
Excellent communication, collaboration and influencing skills at all levels of the organization.
Proficient interviewing and technical writing skills, and attention to detail.
Strong Analytical Skills.
Results Orientated.
Relationship Building.
Mature Confidence and Integrity.
Assertiveness.

Travel
10% Travel

Must be authorized to work in the US. Sponsorship is not available for this position.

Benefits & Company Statement
We believe you should be rewarded for the important work you do. For that reason, you'll receive a competitive compensation and benefits package when you join our team.
It starts with you. That's a simple sentence but it says a lot. It reminds each one of us that what we do matters. Every single McKesson employee contributes to our mission - whatever your title, whatever your role, you act as a catalyst in a chain of events that helps millions of people all over the globe. By... For full info follow application link.

McKesson is an equal opportunity and affirmative action employer - minorities/females/veterans/persons with disabilities.

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Job Posting: 10923298

Posted On: May 12, 2023

Updated On: Jun 11, 2023

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